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UK/HEMA/FME/0922/0005 Date of Preparation: November 2022

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FX CorDiax

Key features
Technology
Performance Data
Studies

High selective permeability for middle molecules

The FX CorDiax is the most efficient dialyser within the FX class^®. The core of the FX CorDiax is the Helixone^® plus membrane, a targeted enhancement of the Helixone^® membrane.

Refined membrane architecture

New production technology combined with INLINE steam sterilisation, allows for crucial enhancements of membrane porosity, reducing flow resistance and improving transport across the membrane.

Benefit of refined membrane architecture

Significantly improved removal of middle molecules while preventing the loss of useful substances, such as serum albumin

Purity enhanced — with steam

The benefits of INLINE steam sterilization
No chemical residuals	No need for gamma sterilization – high energy ionizing radiation can degrade and alter the material chemistry
Low rinsing volumes	Rinsing time and volume is substantially lower compared to gamma sterilized dialyzers
Less rinsing – lower costs	Lower rinsing volumes mean reduced preparation costs

INLINE steam sterilization process

Integrity test

Advances in fibre design allow for the better removal of uraemic toxins

The fibre support region underneath the inner surface has been “opened up”, optimising porosity and therefore also the convective filtration (“flushing”) of larger uraemic toxins such as β2-microglobulin (≈ 11,800 Da) or myoglobin (≈ 17,000 Da)
At the same time, the size of the pores of the inner surface area was not increased to avoid the flushing of albumin

Superior by design

Several state-of-the-art technologies have been combined to create the distinctive, functional features of FX-class^® dialysers, which are refined and optimised for performance and handling:

Design of dialyser housing and fibre bundle for more uniform dialysate flow
Refined blood inlet port for improved haemodynamics

Advances in material and production technologies have allowed for improvements in the wall structure of the Helixone^®plus membrane of the FX CorDiax.

More porous membrane wall for the higher clearance of middle molecules

Optimised dialysate flow	The three-dimensional microwave structure of the fibres ensures uniform radial dialysate flow around each fibre within the bundle by preventing fluid channeling, therefore enhancing clearance values and improving the overall performance of the dialyser.
Better haemodynamics	The lateral blood-inlet port ensures more homogenous blood flow in the dialyser header, preventing stagnation zones. The design essentially minimises the risk of kinking, contributing to improved safety.
Enhanced convection	The more open structure of the Helixone^®plus membrane support region serves to reduce diffusion resistance and increases convective filtration. This facilitates the clearance of a broad range of uraemic toxins, especially the middle molecules.
Kind to the environment	Advanced design goes beyond direct functionality; it also has to be easy on the environment. FX-class^® dialysers weigh half as much as dialysers with polycarbonate housing, and at the same time, use ecologically friendly plastics. This means a lower carbon footprint as a result of fewer materials, less packaging, less fuel for transport and cleaner waste management.

Key to optimal middle molecule removal

Solutes encounter resistance while traversing the membrane wall. Resistance to solute transport is affected in part by pore size at the inner surface and the porosity of the membrane wall. Furthermore, wall structure and thickness, inner fibre dimensions and three-dimensional microwave structure play important roles in transmembrane flux. The new membrane structure of Helixone^®plus allows for the easy passage of middle molecules across the more porous support region of the membrane.

The structure of the support region is crucial to overall performance
Membrane porosity, together with the pore size, regulate the transport of middle molecules

Fibre design for HD

In an HD treatment, reducing the inner fibre diameter from 200 μm (F-series) to 185 μm (FX-class^®) acts to increase internal filtration, thereby increasing the pressure gradient along the length of the fibre. This results in a greater pressure difference between the blood and dialysate compartments. Together with structural refinements to the support region of the fibres, this enables improvements in both diffusive and convective transport, which is of particular importance when performing High-Flux haemodialysis.

Benefit of reduced inner fiber diameter

Fiber pressure profile

Clearance versus the inner diameter of fiber

Design of the HD fiber

A small inner diameter of the hollow fibre increases the pressure gradient between blood and dialysate compartments
The result is improved clearance of middle molecules such as vitamin B12, inulin, β2-microglobulin and myoglobin¹
The increased pressure gradient, combined with structural refinements to the membrane (support region), enhances diffusive as well as convective filtration, especially when performing High-Flux haemodialysis with FX CorDiax

FX CorDiax haemodiafilter

HighVolumeHDF therapy requires specially designed filters. As a result, FX CorDiax haemodiafilters were developed for HighVolumeHDF

Increased fiber lumen for better flow conditions

An increase of its inner diameter results in a reduced pressure drop within a hollow fibre
The capillary diameter of a dialyser can affect performance and treatment quality
The inner diameter of haemodiafilters is 210 μm, compared to 185 μm in HD filters. The larger diameter facilitates improved flow conditions, allowing for higher convective volumes in an HDF treatment.²

The benefit of enlarged fibre lumen in FX CorDiax haemodiafilters

Sieving coefficients of FX CorDiax High-Flux Dialysers and Haemodiafilters

Sieving coefficients of FX CorDiax High-Flux Dialysers and Haemodiafilters	Molecular weight (Dalton)
Albumin	66,500	< 0.001
Myoglobin	17,053	0.5
β2-microglobulin	11,731	0.9
Inulin	5,200	1

Membrane material		Helixone^®plus
Sterilisation method		INLINE steam
Housing material		Polypropylene
Potting compound		Polyurethane
Units per box		24

FX CorDiax High-Flux Dialysers

FX CorDiax High-Flux Dialysers		FX _CorDiax 40	FX _CorDiax 50	FX _CorDiax 60	FX _CorDiax80	FX _CorDiax100	FX _CorDiax120
Clearance (Q_B = 300 mL/min)	Molecular weight (Dalton)
Cytochrome c	12,230	48 *	76	96	111	125	136
Inulin	5,200	56 *	88	116	127	144	149
Vitamin B₁₂	1,355	96 *	144	175	190	207	213
Phosphate	132	142 *	215	237	248	258	262
Creatinine	113	155 *	229	252	261	272	274
Urea	60	175 *	255	271	280	283	284
Clearance (Q_B = 400 mL/min)
Cytochrome c	12,230			100	117	133	145
Inulin	5,200			122	135	154	160
Vitamin B₁₂	1,355			191	209	229	237
Phosphate	132			270	285	299	305
Creatinine	113			290	303	321	325
Urea	60			319	336	341	343
* Clearance (Q_B = 200 mL/min)
Ultrafiltration coeff. (mL/h x mmHg)		21	33	47	64	74	87
In vitro performance: Q_D = 500mL/min, Q_F = 0mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, Q_Bmax, Q_F = 0.2 x Q_Bmax (ISO8637). Ultrafiltration coefficients: human blood (Hct 32%, protein content 6%).
Effective surface (m²)		0.6	1.0	1.4	1.8	2.2	2.5
K₀A Urea		547	886	1,164	1,429	1,545	1,584
Priming volume (mL)		32	53	74	95	116	132
Article number		F00001588	F00001589	F00001590	F00001591	F00001592	F00002384

FX CorDiax Haemodiafilters

FX CorDiax Haemodiafilters		FX _CorDiax 600	FX _CorDiax 800	FX _CorDiax 1000
Clearance (Q_B= 300 mL/min, Q_F = 75 mL/min)	Molecular weight (Dalton)
Cytochrome c	12,230	131	141	151
Inulin	5,200	144	156	166
Vitamin B₁₂	1,355	204	217	225
Phosphate	132	257	267	271
Creatinine	113	271	277	280
Urea	60	285	291	292
Clearance (Q_B = 400 mL/min, Q_F = 100 mL/min)
Cytochrome c	12,230	149	160	172
Inulin	5,200	166	178	190
Vitamin B₁₂	1,355	235	251	262
Phosphate	132	307	321	328
Creatinine	113	327	339	343
Urea	60	354	365	367
Ultrafiltration coeff. (mL/h x mmHg)
In vitro performance: Q_D = 500 mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, Q_Bmax, Q_F = 0.2 x Q_Bmax (ISO8637). Ultrafiltration coefficients: human blood (Hct 32%, protein content 6%).
Effective surface (m²)		1.6	2.0	2.3
K₀A Urea		1,148	1,365	1,421
Priming volume (mL)		95	115	136
Article number		F00001593	F00001594	F00001595

FX CorDiax has a high middle molecule removal capacity

Maduell et al. determined the removal capacity of FX CorDiax 60 compared to FX 60 in HDF postdilution treatments. Significantly higher removal rates were observed with FX CorDiax for:

Urea (60 Da)
β2-microglobulin (11.8 kDa)
Myoglobin (17.2 kDa)
Prolactin (22.9 kDa)
α1-microglobulin (33 kDa)

The authors concluded that “… treating patients with online hemodiafiltration and FX CorDiax 60 instead of FX 60 dialysers results in significantly increased reduction ratios of middle sized molecules without clinically relevant changes in albumin loss.”

“… treating patients with online hemodiafiltration and FX CorDiax 60 instead of FX 60 dialyzers results in significantly increased reduction ratios of middle sized molecules without clinically relevant changes in albumin loss.”

Maduell et. al.

In a postdilution HDF treatment, the use of FX CorDiax 100 dialysers resulted in a significantly higher clearance of β2-microglobulin than in FX 100 and Polyflux^® 210H dialysers. The albumin loss was low and similar for all dialysers.⁴

Comparison of albumin loss in a post-dilution HDF treatment

(QB = 350 mL/min, QD = 800 mL/min, QS = 80 mL/min)⁴

	Albumin loss (g/four hours)
FX CorDiax 100	1.74 ± 1.01
FX 100	2.10 ± 1.00
Polyflux^® 21 OH	1.31 ± 0.12

The phosphate clearance of FX CorDiax dialysers

Comparison of aqueous in-vitro clearances of phosphate (QB = 300 ml/min, QD = 500 ml/min). Investigations carried out by EXcorLab GmbH, an accredited calibration and testing laboratory.

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Additional information relating to multiBic or Calrecia can be found in the critical care section of our product information page.

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UK/HEMA/FME/0922/0005 Date of Preparation: November 2022

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FX CorDiax